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Crescent Biopharma Announces Transformational Partnership with Kelun-Biotech and $185 Million Private Placement, Accelerating and Expanding Global Pipeline of Next Generation Therapeutics for Solid Tumors

On December 04, 2025 (GLOBE NEWSWIRE) — Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported an exclusive partnership with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech") and a comprehensive pipeline update, as well as a $185 million private placement, which is expected to close on or about December 8, 2025, subject to satisfaction of customary closing conditions.

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"We’re excited to share the tremendous progress we’ve made executing on our strategy of building a robust portfolio of next generation oncology therapeutics," said Joshua Brumm, chief executive officer of Crescent. "CR-001, our PD-1 x VEGF bispecific antibody, has the potential to be a foundational immuno-oncology backbone and the partnership we announced with Kelun-Biotech today has enhanced our pipeline of ADCs and accelerated our efforts to deliver potentially best-in-class novel combination therapies. Crescent is now poised to have three distinct programs entering the clinic in 2026 and multiple data readouts anticipated from both monotherapy and novel combination therapy studies by the end of 2027. Additionally, the financing we announced today with leading healthcare investors strengthens our balance sheet, providing anticipated cash runway through multiple key inflection points. Our comprehensive update today underscores Crescent’s commitment to deliver on our vision of building the next leading biotech oncology company."

Kelun-Biotech and Crescent Strategic Partnership

In a separate release today, Kelun-Biotech and Crescent announced a strategic partnership to develop and commercialize next generation oncology therapeutics, including novel combinations. The partnership involves Crescent’s CR-001, a PD-1 x VEGF bispecific antibody, and Kelun-Biotech’s SKB105 (also known as CR-003), an integrin beta-6 (ITGB6)-directed antibody-drug conjugate (ADC) with a topoisomerase payload.

Under the terms of the collaboration, Crescent has granted Kelun-Biotech exclusive rights to research, develop, and commercialize CR-001 in Greater China (including mainland China, Hong Kong, Macau and Taiwan). In addition, Kelun-Biotech has granted Crescent exclusive rights to research, develop, and commercialize SKB105 (CR-003) in the United States, Europe and all markets outside of Greater China. The partnership includes the development of these candidates as monotherapies, and also the evaluation of CR-001 in combination with SKB105 (CR-003). Both Crescent and Kelun-Biotech have the right to independently develop CR-001 in additional combinations, including combinations of CR-001 with proprietary ADC pipeline assets.

Key Pipeline Updates

New details on Crescent’s portfolio, including the clinical development plan for CR-001 as well as supporting preclinical data and plans for its ADC programs, will be shared during today’s conference call and webcast.

CR-001, a PD-1 x VEGF bispecific antibody

CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. It was intentionally designed to replicate the cooperative pharmacology of ivonescimab, which demonstrated superior efficacy results compared to the current market leader, pembrolizumab, in a large, third-party Phase 3 trial in non-small cell lung cancer.1 Because of this similar cooperativity, there is the opportunity for rapid and efficient clinical development for CR-001 as Crescent pursues both first-in-class and fast-follower solid tumor indications.
Crescent is on track to initiate a global Phase 1/2 clinical trial of CR-001 in patients with solid tumors in the first quarter of 2026. The trial is designed to enroll both treatment-naïve and previously-treated patients with multiple solid tumor types, including non-small cell lung cancer and various gastrointestinal and gynecological tumors. The trial plans to include dose-escalation, back-fill and dose-optimization cohorts to enable robust assessment of the clinical profile of CR-001. Crescent anticipates reporting proof-of-concept clinical data from the Phase 1/2 trial of CR-001 in the first quarter of 2027, including safety, pharmacokinetic, pharmacodynamic and early anti-tumor activity.
CR-001’s anti-VEGF activity may normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as the planned administration of CR-001 with ADCs. The partnership with Kelun-Biotech accelerates the scope and number of combination studies planned with CR-001 as a potential foundational immuno-oncology backbone. Crescent plans to evaluate CR-001 in combination with multiple ADCs, including CR-002 and CR-003 (SKB105), with initial combination data expected by year-end 2027.
CR-002, topoisomerase inhibitor ADC targeting PD-L1

CR-002 is a topoisomerase inhibitor ADC directed to PD-L1, a validated target known to have high expression in multiple solid tumors. CR-002 incorporates a PD-L1 antibody selected for high internalization to facilitate payload release in target cells and a linker designed for intracellular cleavage and high stability in circulation.
Crescent is on track to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration for CR-002 in mid-2026 to support the initiation of a Phase 1/2 trial in solid tumors in the second half of 2026, with proof-of-concept data expected in the second half of 2027.
CR-003 (SKB105), topoisomerase inhibitor ADC targeting Integrin beta-6

CR-003 (SKB105), discovered by Kelun-Biotech, is a topoisomerase inhibitor ADC directed to integrin beta-6 (ITGB6), which is overexpressed in many solid tumors with minimal expression in most normal tissues. CR-003 (SKB105) consists of an anti-ITGB6 fully human IgG1 monoclonal antibody conjugated via a stable, clinically validated cleavable linker. CR-003 (SKB105) demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile in preclinical models.
Kelun-Biotech plans to initiate a Phase 1/2 trial of CR-003 (SKB105) in Greater China in the first quarter of 2026, with proof-of-concept data expected in the first quarter of 2027. A combination study of CR-003 and CR-001 is planned to initiate in the first half of 2027 with initial data anticipated by year-end 2027.
Pipeline Expansion Opportunities

Crescent also continues to pursue opportunities to advance its strategy in immuno-oncology and best-in-class ADC combinations through internal efforts and with leading partners, including Kelun-Biotech and Paragon Therapeutics.
Anticipated Milestones

First Quarter of 2026

Initiation of Phase 1/2 trial of CR-001
Initiation of Phase 1/2 trial of CR-003 (SKB105)
Second Half of 2026

Initiation of Phase 1/2 trial of CR-002
Initiation of the first Phase 1/2 ADC combination trial with CR-001
First Quarter of 2027

Proof-of-concept clinical data from Phase 1/2 trial of CR-001
Proof-of-concept clinical data from Phase 1/2 trial of CR-003 (SKB105)
First Half of 2027

Initiation of Phase 1/2 trial of CR-001 in combination with CR-003 (SKB105)
Second Half of 2027

Proof-of-concept clinical data from Phase 1/2 trial of CR-002
By Year-End 2027

Initial clinical data from first ADC combination Phase 1/2 trial with CR-001
Initial clinical data from Phase 1/2 trial of CR-001 in combination with CR-003 (SKB105)
Private Placement Financing

Crescent also announced today that it entered into a securities purchase agreement for a private investment of securities to institutional and other accredited investors that is expected to result in gross proceeds of approximately $185 million to the Company, before placement agent fees and offering expenses. The private placement included participation from both new and existing investors, including Forbion, Fairmount, Vestal Point Capital, BVF Partners, ADAR1, Balyasny Asset Management and Venrock Healthcare Capital Partners.

Pursuant to the terms of the securities purchase agreement, the investors agreed to purchase an aggregate of 13,795,685 ordinary shares of Crescent ("Ordinary Shares") at a purchase price of $13.41 per share (or, for certain investors in lieu of Ordinary Shares, pre-funded warrants to purchase Ordinary Shares). The pre-funded warrants are to be issued for a purchase price equating to $13.409 per pre-funded warrant share (which is the per share purchase price for the Ordinary Shares less the $0.001 per share unfunded exercise price for each pre-funded warrant share) and have an exercise price of $0.001 per share. Following the transaction, there will be approximately 33.3 million Ordinary Shares and Ordinary Share equivalents issued and outstanding, including Ordinary Shares underlying pre-funded warrants and Series A non-voting convertible preferred stock. The PIPE financing is expected to close on or about December 8, 2025, subject to satisfaction of customary closing conditions.

Jefferies, TD Cowen, Guggenheim Securities, Cantor and Wedbush & Co. served as placement agents to Crescent and Piper Sandler served as financial advisor.

The Company intends to use the net proceeds from the private placement, together with the Company’s existing cash and cash equivalents, to advance the preclinical and clinical development of the Company’s product candidates and for working capital and other general corporate purposes. Based on Crescent’s current plans, Crescent believes its existing cash and cash equivalents, together with the net proceeds from the private placement, will be sufficient to fund the Company’s operations and capital expenditure requirements into 2028.

(Press release, Crescent Biopharma, DEC 4, 2025, View Source [SID1234663681])

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Concurrently with the execution of the securities purchase agreement, Crescent and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the Ordinary Shares and the Ordinary Shares issuable upon exercise of the pre-funded warrants, in each case sold in the private placement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Investor Conference Call and Webcast

Crescent will host a conference call and webcast today, December 4, 2025, at 8:00 a.m. ET. To access the conference call, please dial (877)-346-6112 (U.S. & Canada) or +1 (848)-280-6350 (international) at least 10 minutes prior to the start time and ask to be joined into the Crescent Biopharma conference call. A live webcast will be available in the Investors section of Crescent’s website at View Source, and a replay will be accessible for at least 90 days. An accompanying slide presentation will also be available on Crescent’s website at the start of the presentation.

Ascentage Pharma Announces Global Registrational Phase III Study of
Olverembatinib in First-Line Treatment of Ph+ ALL Cleared by US FDA and EMA

On December 4, 2025 Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, reported that it has received clearance from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct a global registrational Phase III study (POLARIS-1; NCT06051409) of its compound under investigation, olverembatinib, in combination with chemotherapy for the treatment of newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). As the second global registrational Phase III study of olverembatinib that has been cleared by regulators in the US and Europe, the POLARIS-1 study is simultaneously enrolling patients across trial centers in multiple countries in order to accelerate olverembatinib’s path to registration worldwide, particularly in the US and European markets.

The POLARIS-1 trial is a global, multicenter, randomized controlled, open-label Phase III study designed to evaluate the efficacy and safety of olverembatinib in combination with chemotherapy in newly diagnosed patients with Ph+ ALL. The POLARIS-1 study was also initiated in China after it was cleared by the China Center for Drug Evaluation (CDE) in 2023.

The POLARIS-1 study is set to release its first dataset at the upcoming 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Data disclosed in the ASH (Free ASH Whitepaper) 2025 abstract showed that among treatment-naïve patients with Ph+ ALL who received olverembatinib in combination with low-intensity chemotherapy, the minimal residual disease (MRD) negativity rate and the molecular MRD-negative complete response (CR) rate at the end of three treatment cycles both reached approximately 65%, which significantly improved the efficacy reported for other drugs in the same class. Notably, the combination regimen also demonstrated favorable clinical benefit in patients with certain high-risk subtypes such as those harboring the IKZF1plus mutation. In addition, the combination regimen demonstrated a favorable safety profile, with a low incidence of adverse events which were mostly manageable.

Accounting for 20%-30% of all ALL cases in adults, Ph+ ALL is commonly associated with a disproportionately high incidence in the elderly population, a high relapse rate, short disease-free survival, and poor prognosis. Prior to the introduction of tyrosine kinase inhibitors (TKIs), chemotherapy-only treatment delivered a five-year overall survival (OS) rate of less than 20%. The clinical adoption of TKIs has resulted in a new clinical paradigm for patients with Ph+ ALL. However, first- and second-generation TKIs have considerable limitations in the treatment of Ph+ ALL.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, "Clearances from the U.S. FDA and the EMA for this global registrational Phase III study mark a significant step forward in the global development of olverembatinib in Ph+ ALL. Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will press ahead with the clinical development of olverembatinib in Ph+ ALL and strive to bring a new treatment option to patients around the world as soon as possible."

Developed by Ascentage Pharma, olverembatinib is an orally administered, third-generation TKI and the first China-approved third-generation BCR-ABL inhibitor, currently being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. Olverembatinib has already been approved in China in multiple indications in drug-resistant chronic myeloid leukemia (CML) and all of the approved indications are now covered by the China National Reimbursement Drug List (NRDL). Being developed for the treatment of Ph+ ALL, olverembatinib has received consecutive recommendations in the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Hematologic Malignancies and a Breakthrough Therapy Designation by the China CDE.

On June 14, 2024, Ascentage signed an exclusive option agreement to enter into an exclusive license agreement with Takeda for olverembatinib. In the event that Takeda exercises the option, Takeda would license the global rights to develop and commercialize olverembatinib in all territories outside of, among others, mainland China, Hong Kong, Macau, and Taiwan, China.

* Olverembatinib is currently under investigation and has not yet been approved by the FDA in the US.

(Press release, Ascentage Pharma, DEC 4, 2025, View Source [SID1234663141])

Estrella Advances STARLIGHT-1 Trial into Phase II Following Positive DSMB Recommendation

On December 4, 2025 Estrella Immunopharma, Inc. (NASDAQ: ESLA) ("Estrella" or the "Company"), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS T-cell therapies to treat cancer and autoimmune diseases, reported that an independent Data Safety Monitoring Board (DSMB) has completed its review of safety data from the Phase I dose escalation portion of the STARLIGHT-1 trial. Based on the favorable safety profile observed, the DSMB recommended advancing the trial to Phase II, or the expansion phase, at the Recommended Phase II Dose (RP2D). The expansion phase will further evaluate the safety and preliminary efficacy of EB103, the Company’s CD19-redirected ARTEMIS T-cell therapy, in patients with relapsed/refractory (R/R) B-cell non-Hodgkin’s lymphoma (NHL).

In the Phase I dose escalation phase, no treatment-related serious adverse events (SAEs) were reported (n=9). Notably, the majority of patients treated are considered high-risk, including one with Central Nervous System (CNS) lymphoma. The high-dose cohort achieved a 100% complete response (CR) rate at Month 1 in all evaluable patients.

"The advancement of EB103 into the expansion phase of STARLIGHT-1 is a pivotal milestone for Estrella," said Cheng Liu, PhD, Chief Executive Officer of Estrella. "The excellent safety profile and a 100% complete response rate observed in the high-dose cohort in Phase I demonstrated EB103’s potential to overcome the toxicity barriers that have historically restricted CD19 CAR-T use. We believe EB103 may significantly expand the commercial reach of cell therapy and deliver a best-in-class solution to a broader NHL population, including high-risk subgroups previously ineligible for commercial CAR-T."

The expansion phase is designed as a multi-center, open-label study intended to further evaluate the safety and efficacy of EB103 at the RP2D in subjects (≥ 18 years of age) who have R/R B-cell NHL. Data from this expansion cohort will be used to determine the pivotal trial strategy for EB103. Current active sites include UC Davis Comprehensive Cancer Center and Baylor Scott & White Research Institute. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06343311.

About EB103

EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. ("Eureka"), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, like EB103 T-cell, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from an endogenous T-cell receptor. Once infused, EB103 T cells bind to and destroy CD19-positive cancer cells.

(Press release, Estrella Biopharma, DEC 4, 2025, View Source [SID1234661152])

Mission Bio’s Tapestri Single Cell Multi-Omics Platform for Exploratory Biomarker Analysis Supports Myeloproliferative Neoplasms (MPNs) Data Presentation at ASH 2025

On December 4, 2025 Mission Bio, Inc., a leader in single-cell multi-omic solutions for precision medicine, reported that its Tapestri Platform and custom assay development supported initial exploratory biomarker analysis data presented by Incyte at the ASH (Free ASH Whitepaper) 2025 conference in Orlando, Florida, in December. The data demonstrate Tapestri Platform’s ability to accelerate the understanding of Myeloproliferative Neoplasms (MPNs) disease biology at the single-cell level.

Myeloproliferative neoplasms (MPNs) are a type of blood cancer caused by genetic mutations in blood-forming stem cells. These mutations—found in the JAK2, TPO-R, or CALR genes—lead to uncontrolled growth of certain blood cells. INCA033989, an investigational monoclonal antibody, targets mutant calreticulin (CALR), a key driver in MPN pathogenesis.

The data presented at ASH (Free ASH Whitepaper) 2025 illustrate how the Tapestri’s single-cell data was leveraged to understand disease persistence and clonal expansion in MPNs. Subsequently, Tapestri’s single-cell DNA and protein profiling was applied to gain deeper insights into clonal evolution, disease progression, and treatment response in patients with MPNs.

The Tapestri Platform enables high-resolution detection of co-occurring mutations and cell surface protein expression, providing a more comprehensive picture of tumor heterogeneity and immune interactions in MPNs. By incorporating Mission Bio’s single-cell technology, Incyte was able to better characterize clonal diversity, track resistance mechanisms, and refine patient stratification strategies to help advance the development of precision therapies for MPNs.

"Our collaboration with Incyte highlights the role of single-cell multi-omics as an advanced clinical biomarker tool and the potential power of single-cell analysis in supporting targeted therapy development in the clinic," said Brian Kim, CEO at Mission Bio. "By unraveling the complexity of MPNs at the single-cell level, we can enhance complex biomarker analysis for targeted therapies in this space."

To learn more about Mission Bio, the Tapestri Platform, and Pharma Assay Development (PAD) services, please visit www.missionbio.com.

(Press release, Mission Bio, DEC 4, 2025, View Source [SID1234661151])

Orano Med Enters Next Phase of Collaboration with Roche

On December 4, 2025 Orano Med, a subsidiary of the Orano group specializing in nuclear medicine, reported that its long-standing collaboration with the multinational pharmaceutical company Roche (SIX: RO, ROG; OTCQX: RHHBY) is entering the next phase. Over the past years, the companies have conducted extensive preclinical research to develop a potential novel cancer treatment approach called "two-step pretargeted radioimmunotherapy" (or PRIT). This innovative technology, which pretargets the tumor with an antibody that is subsequently able to capture chelated lead-212 (212Pb) to target tumor cells, is now ready to advance into clinical development in humans. Orano Med will be responsible for the manufacturing of 212Pb, utilizing its industrial manufacturing platform in France and the US.

Nicolas Maes, Chief Executive Officer of the Orano group, commented: "We are very pleased about the progress made in collaboration with Roche for the development of a potential new treatment approach for cancer patients. After the licensing agreement signed with Sanofi last year for our most advanced clinical program, AlphaMedix, the achievement with this potential new drug candidate marks an important milestone that we accomplished jointly with another major player in the pharmaceutical industry. It illustrates our capacity to execute our long-term strategy, aimed at developing a solid pipeline of 212Pb-targeted alpha therapies to treat multiple oncology indications. In addition, thanks to the Orano Group’s expertise in the nuclear industry and its access to thorium-232, a scarce raw material required for producing 212Pb, Orano Med is also responsible for the entire production and distribution chain for these isotopes."

Julien Torgue, Chief Scientific Officer of Orano Med, commented: "The application of two-step pretargeted radioimmunotherapy represents a potentially game-changing advancement in radioligand therapies and cancer treatment more broadly. Instead of delivering radiation and targeting vector together, the novel technique separates the process into two precise steps: first, allowing time for antibodies to accumulate on the tumor, and then capturing the alpha particle emitting radioactive isotope lead-212, which allows for the precise targeting of cancer cells while sparing healthy tissue. In preclinical studies, we could already demonstrate both strong efficacy and, importantly, a reduction in off-target uptake in healthy tissues. If these results translate to the clinic, this could bring us a major step closer to a more effective and for patients also safer form of radioligand therapy. We are looking forward to further continue the development of this innovative approach with Roche."

Under the terms of the agreement, Orano Med and Roche have committed to develop this new therapeutic solution targeting a specific antigen known as carcinoembryonic (CEA), a cell surface glycoprotein overexpressed in several cancers. This antigen serves as a marker for various types of cancer, such as colorectal, pancreatic, and gastric cancers, as well as certain lung cancers. These are cancers for which the current therapeutic options are often limited or insufficient to meet patients’ needs. CEA shows restricted expression in normal tissues, making it a very suitable target for antibody-based therapies and radioimmunotherapy.

The Roche sponsored phase 1 clinical trial is expected to start in the first half of 2026, initiating the development of a broader platform dedicated to alpha radioimmunotherapies, underscoring Orano Med’s global leading position in the field of targeted alpha therapies.

About 212Pb two-step PRIT
Compared with conventional radioligand therapies (RLT), where the isotope and targeting moiety are co-delivered, pretargeted radioimmunotherapy (PRIT) uses a sequential approach. A tumor-targeting bispecific antibody (bsAb) is first administered, followed by a radioligand carrying the radioactive payload. The delay gives the bsAb the necessary time to accumulate on the tumor cells while unbound radioligand is rapidly cleared. It thus enables highly specific antibody targeting while remaining compatible with the relatively short half-life of 212Pb (10.6 hours). By introducing the cytotoxic radioligand only after the bsAb has largely cleared from circulation, radiation is concentrated in the tumor. This sequential approach is designed to minimize systemic radiation exposure, achieve high tumor-to-nontumor ratios, and thus improve safety and tolerability compared to other RLTs.

One of the main challenges of the PRIT approach has been to ensure fast excretion of the radioactive payload while maintaining high affinity for the slower-clearing pretargeting molecule. An intermediate step to clear or neutralize circulating pretargeting antibodies has often been employed to prevent off-tumor capture of the radioligand, but this adds complexity and safety risks, posing challenges to the clinical implementation of PRIT.

The new approach developed by Roche and Orano Med represents a novel two-step PRIT regimen for CEA-positive tumors that eliminates the need for an intermediate clearance step. This strategy combines a complementary bispecific antibody pair with the chelated ²¹²Pb, demonstrating both high efficacy and improved tolerability in preclinical studies compared with three-step PRIT.

Preclinical studies have confirmed proof of mechanism and therapeutic efficacy of the two-step PRIT, showing a favorable biodistribution with substantial uptake in CEA-positive tumors and rapid clearance of unbound 212Pb-DOTAM, with limited accumulation in kidneys and other organs. This confirms the excellent 212Pb tumor specificity and its high potential to significantly delay tumor growth.

(Press release, Orano Med, DEC 4, 2025, View Source [SID1234661150])